B. Braun Medical, Inc.: NORM-JECT Syringes Recalled for Potential Sterility Compromise

Agency Publication Date: September 27, 2023

Summary

B. Braun Medical, Inc. is recalling approximately 1,138,800 units of NORM-JECT 10 ml syringes, including both Luer Solo and Luer Lock Solo models. These medical devices are being recalled because the sterile blister packaging may be damaged, which could compromise the sterility of the syringe inside. While no specific injuries have been reported in this notice, using a non-sterile syringe to inject or withdraw fluids from the body can lead to serious infections. These syringes were distributed nationwide, specifically through Air-Tite Products Co., Inc. in Virginia.

Risk

If the protective blister packaging is punctured or torn, the syringe is no longer sterile and may be contaminated with bacteria or other pathogens. Injecting fluids with a contaminated syringe can introduce infections directly into a patient's bloodstream or tissue.

What You Should Do

Identify your product by checking the packaging for B. Braun NORM-JECT Luer Solo (10 ml) with REF: NJ-4606108-02 or B. Braun NORM-JECT Luer Lock Solo (10 ml) with REF: NJ-4606728-02.
Check your specific lot numbers and UDI-DI codes. Affected Luer Solo lots are 22M28C8 and 23A09C8 (UDI-DI: 04046955597031). Affected Luer Lock Solo lots are 22M21C8 and 23A09C8 (UDI-DI: 04046955597185).
Immediately stop using any syringes from the affected lots and quarantine them to prevent accidental use.
Contact your healthcare provider if you have used these syringes and have concerns about potential infection or side effects.
Contact B. Braun Medical, Inc. or your distributor, Air-Tite Products Co., Inc., for instructions on returning the affected products and obtaining replacements or credit.
For further information, you can contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer/Healthcare provider consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: B. Braun NORM-JECT Luer Solo (10 ml)

Model / REF:

REF: NJ-4606108-02

Recall #: Z-2643-2023

UPC Codes:

04046955597031

Lot Numbers:

22M28C8

23A09C8

Product: B. Braun NORM-JECT Luer Lock Solo (10 ml)

Model / REF:

REF: NJ-4606728-02

Recall #: Z-2644-2023

UPC Codes:

04046955597185

Lot Numbers:

22M21C8

23A09C8

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92910

Status: Active

Manufacturer: B. Braun Medical, Inc.

Sold By: Air-Tite Products Co., Inc

Manufactured In: United States

Units Affected: 2 products (534,000 units; 604,800 units)

Distributed To: Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your product by checking the packaging for B. Braun NORM-JECT Luer Solo (10 ml) with REF: NJ-4606108-02 or B. Braun NORM-JECT Luer Lock Solo (10 ml) with REF: NJ-4606728-02.

Check your specific lot numbers and UDI-DI codes. Affected Luer Solo lots are 22M28C8 and 23A09C8 (UDI-DI: 04046955597031). Affected Luer Lock Solo lots are 22M21C8 and 23A09C8 (UDI-DI: 04046955597185).

Immediately stop using any syringes from the affected lots and quarantine them to prevent accidental use.

Contact your healthcare provider if you have used these syringes and have concerns about potential infection or side effects.

Contact B. Braun Medical, Inc. or your distributor, Air-Tite Products Co., Inc., for instructions on returning the affected products and obtaining replacements or credit.

For further information, you can contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: B. Braun NORM-JECT Luer Solo (10 ml)

Model / REF:

REF: NJ-4606108-02

Recall #: Z-2643-2023

UPC Codes:

04046955597031

Lot Numbers:

22M28C8

23A09C8

Product: B. Braun NORM-JECT Luer Lock Solo (10 ml)

Model / REF:

REF: NJ-4606728-02

Recall #: Z-2644-2023

UPC Codes:

04046955597185

Lot Numbers:

22M21C8

23A09C8